Disposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 30 P.S.I., max. 1267.NMD

GUDID 08717872001395

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ophthalmic surgical instrument handle, pneumatic
Primary Device ID08717872001395
NIH Device Record Key2bf618b8-8ec0-4a51-b011-79d50d5f9a6f
Commercial Distribution Discontinuation2023-09-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDisposable Pneumatic Vitrectome.(20 gauge / 0.9 mm)(working with 30 P.S.I., max.
Version Model Number1267.NMD
Catalog Number1267.NMD
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872001395 [Primary]
GS118717872001392 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-09-15
Device Publish Date2016-09-30

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